Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives.
Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.
Nestlé Skin Health is a subsidiary of Nestlé.
For our Global SIG Rx organisation, we are currently looking for :
Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Clinical studies management :
The Senior Clinical Trial Administrator (Sr. CTA) administers, maintains and coordinates the logistical aspect of clinical trials, according to GCP (good clinical practice) guidelines and relevant SOP’s (standard operating procedures).
The Sr. CTA acts as a main point of contact for the clinical trial team and the study site staff and coordinates the overall management of clinical trial documentation within a clinical program.
Activities and responsibilities :
Ensures proper collection, filing, tracking and storage of clinical trial documentation in support and at the direction of the Clinical Project Manager (CPM)
Transfers clinical documentation to regulatory for regulatory filings
Collaborates with the Clinical Research Associates (CRA) and Clinical Project Manager (CPM) during clinical research hard copy and e-documentation process
Calculates investigator fees in accordance with contractual agreements.
May oversee Regular CTAs.
Overall responsibility of Trial Master File (TMF) : set up, maintenance & archiving for in-sourced or outsourced studies.
Control administrative work ensuring CRO maintains a complete trial master file & organized shipment to Galderma in the appropriate format at the end of the study.
For in-sourced studies assures filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.
Complete TMF Quality Control and subsequent Quality Assurance audit resolution including drug reconciliation documentation in collaboration with clinical team;
Assures administrative archiving of the TMF. E-filing of essential documents in documentum. E-filing of internal metric in appropriate tool.
Assist in study start-up : Regulatory binders, investigator recruitment tasks, investigator meetings, presentations, etc.
Collect, control and submit initial and subsequent regulatory documents to IECs (including protocol and amendments) and, collaborate with Regulatory group.
Obtain signatures necessary for the conduct of the trial, from drug release through final archive.
Serve as the contact and / or liaison for the CRO and Investigative sites for regulatory documents, clinical supplies, CRFs, study agreement (financial contract), and other pertinent administrative matters under the supervision of the CPM.
Follow the study budget closely and keep the CPM informed. Process invoices and Investigator payments after appropriate approval obtained.
Assemble final report appendices and ensure final report completeness in collaboration with clinical team.
Organize and conduct formal presentations at meetings and training sessions, as applicable.
On an as needed basis may help the team with writing of some clinical documents.
Assist with training and mentoring new / junior CTAs.
Identification of needs.
Provide clear feedback to Manager on progress.
Perform other duties assigned by Management.
Expected qualifications :
University degree, preferably in life sciences or equivalent qualification.
Minimum of 5 years of relevant clinical trial administration experience.
Drug / device combination and biologics experience preferred.
Good command of MS Office applications and ability to learn and to adapt to work with IT systems.
High degree of analytical thinking, the ability to critical reasoning, effective planning and organizational skills with result oriented approach.
Fluent in English
Location : Lausanne Region, Switzerland.
Date : As of Q2 2018